The US Food and Drug Administration (FDA) has cleared Hologic’s first gastrointestinal (GI) pathogen detection tests.
The FDA clearance for the Panther Fusion GI Bacterial and Expanded Bacterial Assays coincides with the tests’ receipt of a CE mark in Europe.
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The US-based company’s new GI pathogen detection tests cover common bacterial causes of infectious gastroenteritis, including Salmonella, Campylobacter, Shigella, E. coli, Vibrio, Yersinia and Plesiomonas.
According to Hologic, the tests’ ability to be run together or in any combination mitigates the labour-intensive and time-intensive barriers associated with the traditional identification of pathogens that result in diarrheal illness by applying biochemical and microscopy-based testing.
Research indicates that almost 200 million cases of infectious gastroenteritis occur annually, with up to three million necessitating ambulatory visits.
Hologic’s diagnostic solutions president Jennifer Schneiders said: “At Hologic, we recognise that access to a comprehensive range of accurate and fully automated diagnostic tests is essential for laboratories and their patients.
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By GlobalData“FDA clearance and CE marking of our first GI pathogen detection tests reflect our dedication to advancing diagnostic innovation, and equipping laboratories and clinicians globally with the tools they need to provide fast and informed care when time matters most.”
Hologic’s entry into the gastrointestinal assay space is likely a direct consequence of its $159m acquisition of Diagenode in 2021. Prior to its buyout, the company held more than 30 proprietary real-time polymerase chain reaction (PCR) tests for gastroenteritis and other indications, including sexually transmitted infections (STI) and meningitis.
Other players in the assay space to have received clearance on GI panels in 2025 include Qiagen, with its QIAstat-Dx syndromic testing analyser, the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral). The company’s test covers five causes of gastrointestinal illness – Campylobacter, Salmonella, shiga-like toxin E. coli (STEC), Shigella, and norovirus – as recommended by the Infectious Diseases Society of America (IDSA).
Hologic’s clearance follows the FDA’s decision to rescind its Final Rule that would have classified laboratory-developed tests (LDT) as medical devices, following the rule being struck down in a Texas court earlier this year.
10xBeta’s CEO Marcel Botha told Medical Device Network that in his view, the FDA elected not to challenge the court decision on the rule having realised it would amount to a “battle about the wrong thing”.
Botha explained: “They too want efficiency and agency where it matters, both to enhance and improve patient access, and reduce costs and improve throughput. And the Final Rule was diametrically opposed to achieving that goal for the current administration.”
